What Statice does

Statice is a France-based, privately-held Contract Design and Manufacturing Organization (CDMO) founded in 1978 in Besançon that develops and produces Class I to III medical devices for startups, SMEs, and major medical device companies. The company operates across four integrated service lines — R&D and product development, Verification and Validation (V&V), Regulatory Affairs, and Contract Manufacturing — and maintains its own ISO 13485-certified quality management system spanning CE marking (EU/MDR), FDA (US), ANVISA (Brazil) and CFDA (China) homologations.

The company's core technology platform centers on microtechnology and biocompatible polymer transformation. Statice has specialized in implantable-grade silicone processing since 1990 (HCR and LSR, Shore 00 to 80A), thermoplastic micro-injection in PEEK and polyurethanes, biorésorbable materials processing (PGA, PLLA, PCL, PDO) including electrospinning for tissue engineering, and mecatronics for Active Implantable Medical Devices (DMIA). All production is performed in ISO 7 clean rooms, with internal tooling design, micro-laser welding, advanced metrology, and validated assembly processes. The company produces devices across seven therapeutic domains: cardiology/angiology, neurology, endoscopy/robotics, urology/gynecology, orthopedics, ophthalmology, and oncology/laboratory diagnostics.

Statice generates revenue through project-based development fees, regulatory consulting, and series manufacturing contracts that range from a few units per year (implants, mechatronic devices) to tens of thousands (catheters, silicone parts). Manufacturing is split between the Besançon headquarters (1,000 m² ISO 7 clean rooms plus a 1,000 m² extension building) and a wholly-owned Mauritius production facility in a best-cost zone. As of recent disclosures, the company employs approximately 150-160 people, generates €15 million in annual revenue, and is owned by its founders/management team with no institutional investor or parent-company structure.

Name

Statice

Legal name

STATICE MANUFACTURING (STATICE SANTE)

Website

https://statice.com

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

101–250 employees

Short description

Statice is a France-based, privately-held medical device CDMO founded in 1978 that provides R&D, regulatory, and series manufacturing services for Class I-III medical devices across seven therapeutic areas, serving startups, SMEs, and major medtech firms from two ISO 7 clean room sites in Besançon and Mauritius.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing (CDMO)

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

Keywords

• Medical device manufacturing
• Contract design services
• Biocompatible polymer processing
• Clean room production
• Regulatory affairs consulting

Headquarters

HQ city

Besançon

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain

Revenue model

1. Contract Design and Manufacturing Services: STATICE operates as a CDMO providing end-to-end medical device development and manufacturing services. Revenue is generated through project-based consulting (R&D, regulatory affairs) and series production contracts. The company develops Class I to III medical devices ready for sterilization, serving clients from concept through first-in-human trials and commercial production ramp-up.
2. Series Manufacturing of Medical Devices: Production capacity ranges from a few units per year (mechatronic devices, implants) to tens of thousands of devices (catheters, silicone parts). Manufacturing is split between two sites (Besançon, France and Mauritius) with 1000 m² of ISO 7 clean rooms and 400 m² of mechatronics assembly workshops. Production is released ready-to-sterilize with full traceability via ERP system.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Statice is a Contract Design and Manufacturing Organization (CDMO) providing integrated medical device development services spanning R&D and design, verification and validation (V&V), regulatory affairs, and series production. The company serves medical device manufacturers (startups, SMEs, and major medtech firms) developing Class I to III devices, using microtechnology expertise in biocompatible polymer transformation (silicone, thermoplastics, biorésorbables), mechatronics, clean room assembly, and metrology under an ISO 13485-certified quality system across facilities in Besançon (France) and Mauritius.

Product overview

Statice is a CDMO (Contract Design and Manufacturing Organization) providing integrated services from R&D through production of medical devices. The company operates four interconnected service lines: R&D & Development Services (multidisciplinary engineering with CAO, prototyping, industrialization), Verification & Validation (V&V) for regulatory compliance and testing, Regulatory Affairs (RA) for CE/FDA/ANVISA approvals, and Contract Manufacturing for series production. Supporting these core services are specialized technology capabilities including Silicone Transformation, Thermoplastic Injection, Bioresorbable Materials Processing, Mechatronics, Assembly Processes, and Metrology. The company produces medical devices across seven therapeutic domains: Cardiology/Angiology, Neurology, Endoscopy/Robotics, Urology/Gynecology, Orthopedics, Ophthalmology, and Oncology/Laboratory.

Differentiator

Problem solved

Functional benefit

Products and services

• R&D and Development Services Multidisciplinary engineering bureau providing design, prototyping, and industrialization of Class I to III medical devices, including CAO (Solidworks), simulations, proof of concept, and first-in-human manufacturing. Targeted at medical device startups, SMEs, and major medtech companies.
• Verification and Validation (V&V) Biomedical engineering team handling regulatory compliance, validation planning and execution including performance testing, electrical validation per IEC 60601, software validation per IEC 62304, and special manufacturing process validation. Targeted at medical device manufacturers seeking regulatory compliance for CE/FDA/ANVISA/CFDA market entry.
• Regulatory Affairs (RA) Regulatory consulting services for CE marking, FDA, ANVISA, and international market approvals, including technical file preparation, biocompatibility assessment, and quality management system implementation. Targeted at medical device companies seeking homologation across EU, US, Brazil, and Chinese markets.
• Contract Manufacturing Series production of medical devices ready for sterilization, including assembly in ISO 7 clean rooms, mechatronic assembly, packaging, UDI-compliant labeling, and supply chain management. Production capacity ranges from a few units per year for mechatronic devices and implants to tens of thousands of devices for catheters and silicone parts. Targeted at medical device manufacturers across startups, SMEs, and major companies.

Quantifiable outcome

• Developed and transferred to production numerous CE/FDA/ANVISA-approved medical devices across cardiology, neurology, urology, ophthalmology, orthopedics, endoscopy, and oncology.

Named customers1 record

Segments1 record

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• FEMTO-STcoreStrategic or Co-development PartnerFEMTO-ST is a leading French research laboratory in microtechnics and physics. As part of the Besançon microtechnology ecosystem, STATICE leverages FEMTO-ST for advanced research collaborations and access to cutting-edge microtechnology expertise, drawing on the region's historic watchmaking precision.
• SupmicrotechcoreStrategic or Co-development PartnerSupmicrotech (École Supérieure de Microtechnique) is a leading French engineering school located in Besançon, part of the ENSMM. As a founding member of the ISIFC biomedical engineering chair, Supmicrotech is a key talent pipeline and research partner for STATICE.
• ISIFC (Institut Supérieur d'Ingénierie Biomédicale)coreStrategic or Co-development PartnerISIFC is the first French engineering school dedicated to biomedical engineering, located in Besançon. STATICE is a founding member of the ISIFC industrial chair and an engaged actor within the school, providing both talent recruitment and collaborative R&D opportunities.
• UTBM (Université de Technologie de Belfort-Montbéliard)minorStrategic or Co-development PartnerUTBM is a technology university in the Franche-Comté region, contributing to the engineering talent ecosystem that supports STATICE's R&D and manufacturing activities.
• GMED / LNEcoreOthersGMED (Groupe LNE) is a Notified Body for medical device certification under EU MDR. STATICE works with GMED for CE marking and regulatory certification of devices developed and manufactured at its facilities.
• PMT Santé (Pôle des Microtechniques)minorStrategic or Co-development PartnerPMT Santé is the health technology cluster within the Pôle des Microtechniques, a regional industry cluster in Besançon. STATICE is an engaged member, leveraging the cluster for networking, partnerships, and industry visibility.
• France InnovationminorStrategic or Co-development PartnerFrance Innovation is a national innovation association. STATICE maintains membership for industry visibility, networking, and access to innovation support programs.
• ASRC (À la source de l'innovation pour l'industrie)minorStrategic or Co-development PartnerASRC is an innovation association in the industry sector. STATICE is listed as a partner/member on its website.
• Specialized Thermoplastic Tube SubcontractorsminorChannel Partner/ Reseller/ DistributorSTATICE has developed partnerships with a network of expert subcontractors for multi-lumen thermoplastic tubes and braided tubes. STATICE performs tip forming and tube welding operations in-house.

Scale indicators5 records

Recent moves12 records

Expansion highlights5 records

Direct peers

• Cirtec Medical: US-based CDMO specializing in active implantable medical devices, neuromodulation, and miniaturized catheter systems. Directly comparable to Statice's AIMD/DMIA and active catheter capabilities, with similar mid-sized scale.
• Resonetics: Medical device CDMO with strong capabilities in nitinol, micromachining and catheter-based components. Comparable niche positioning in Class II/III interventional devices and micro-component manufacturing.
• Spectrum Plastics Group: Specialty medical device manufacturer focused on polymer-based components, tubing and catheters. Comparable to Statice's silicone/thermoplastic processing and catheter manufacturing capabilities.
• VOSS Biomedical: German medical device CDMO focused on polymer components and contract manufacturing for implants and Class III devices. Comparable to Statice in size, European footprint, and polymer-processing specialization.

Broad incumbents

• Sanmina: Global EMS provider with a dedicated Medical division serving Class II/III OEMs. Comparable service scope (design through manufacturing) but at much larger scale and broader geographic reach.
• Integer Holdings: Large global medical device contract manufacturer and OEM serving cardiac, neuromodulation and surgical markets. Competes with Statice on Class II/III programs at substantially greater scale and geographic reach.
• Creganna Medical (TE Connectivity): TE Connectivity's medical business, specializing in catheter-based delivery systems and minimally invasive device components. Direct overlap with Statice's cardiology, neurology and endoscopy device capabilities.
• Flex Medical Solutions: Medical device and diagnostics manufacturing arm of Flex, offering integrated design, tooling, sterilization management and series production. Competes for the same outsourced medical device programs as Statice, with global footprint.
• Jabil Healthcare: Division of Jabil providing medical device design, manufacturing and supply chain services at global scale. Overlaps with Statice's contract manufacturing capabilities but serves much larger OEMs across multiple geographies.

Emerging players

• Austar Medical: China-based medical device CDMO offering contract manufacturing and assembly services for global MedTech clients. Emerging player with growing overlap in catheter and polymer-based device manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/statice-innovation

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Statice